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Parental Monitoring Of Blood Glucose

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Diabetes is one of the biggest epidemic crises of the 21century. Uncontrolled diabetes is associated with microvascular and macrovascular complications. Tight glycemic control has been linked to a reduction in the development of these complications in both type 1 and type 2 diabetes. The invention of Glucose Meter has changed the diabetes care by enabling patients to monitor their blood glucose level according to their diet, medications and activity. control of glycaemia within the established recommended values is a major therapeutic goal for diabetic patients both in the hospital and outpatient setting. Using of self monitoring of blood glucose 9SMBG0 devices will help diabetic patients detect, prevent or manage of hypo- and hyper …show more content…

There are no single standard criteria to assess the accuracy of a glucose meter so the measurement of accuracy will vary by region and recommendation used for judgment. in the past, five sets of criteria for glucose meter`s performance were used in the accuracy assessment. Criteria which are set by the National Committee for Clinical Laboratory Standards, the American Diabetes Association (ADA) in 1987 and 1996, the U.S. Food and Drug Administration which are according to either the blood glucose level is <50–70 mg/dl. In 2013 new, tighter accuracy standards (ISO: 15197:2013) were drawn up, requiring that 95% of blood glucose results should reach the following standard: Within ± 0.83 mmol/L of laboratory results at concentrations of under 5.6 mmol/L (Within ± 15 mg/dl of laboratory results at concentrations of under 100 mg/dL) and Within ± 20% of laboratory results at concentrations of 5.6 mmol/L (100 mg/dL) or more. The 2014 U.S. Food and Drug Administration (FDA) draft guidance for over-the-counter BGMs requires 95% of results within ±15% and 99% of results within ±20% across the whole glycaemic range.
Clinical accuracy

Clinical accuracy compares the medical decisions based on the test result. It depends on how the result will be used in patient care: for screening, management or diagnosis. For patients and health professionals, it is important to be sure that glucose meter accuracy

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